CSL Behring
Senior Biostatistician(m/w/x)
Full-timeOn-siteSenior
Glattbrugg
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CSCSL Vifor
Associate Director, Biostatistics(m/w/x)
Glattbrugg
Full-timeOn-siteSenior
Nejo AI Summary
Leading biostatistics for innovative therapies in iron deficiency and nephrology, defining strategies for clinical trials and regulatory submissions. 8+ years drug development experience with statistical leadership at compound/indication level required. Global project scope in precision healthcare.
Requirements
- PhD or MS in Biostatistics, Statistics, or related field
- PhD with 8 years or MS with 11 years experience in drug development
- Statistical leadership experience at compound/indication level
- Statistical expertise and leadership in clinical development strategy
- Solid experience in advanced statistical methodologies
- Leading roles in regulatory submissions
- Experience in interactions with major regulatory authorities (preferred)
- Experience with CROs or managing internal deliveries (preferred)
- Track record of innovation (preferred)
- Familiarity with regulatory guidance and interactions
- Broad knowledge of clinical development and processes
- Collaborative work and leadership in matrix environment
- Strong interpersonal and communication skills (verbal and written in English)
- Good working knowledge of SAS and/or R
- Expertise in a range of statistical methodologies
- Innovative/creative methodology for clinical data analysis
- Familiarity with relevant regulatory guidance documents
- Expertise in
- CDISC, statistical programming, and/or data standards
Tasks
- Lead biostatistics for assigned therapeutic programs.
- Define statistical strategies for clinical trials.
- Define statistical strategies for regulatory submissions.
- Ensure appropriate statistical methodologies for study design and data analysis.
- Influence and contribute to clinical development plans.
- Collaborate with cross-functional teams on governance reviews.
- Lead statistical strategy for study planning and execution.
- Lead quantitative evaluations for clinical trials and regulatory submissions.
- Lead quantitative evaluations for related documents.
- Provide statistical thought partnership for innovative study design.
- Provide statistical thought partnership for clinical development plans.
- Develop Go-No Go criteria.
- Perform probability of technical success calculations.
- Plan analyses across all projects.
- Ensure quality and timely delivery of interim results.
- Ensure quality and timely delivery of final results.
- Deliver integrated analyses for submissions.
- Represent Biostatistics to regulatory authorities.
- Interpret analysis results.
- Ensure reporting accuracy in study reports.
- Ensure reporting accuracy in regulatory documents.
- Manage biostatistics outsourcing operations.
- Collaborate with internal statistical programmers.
- Ensure timeliness of CRO/FSP deliverables.
- Ensure quality of CRO/FSP deliverables.
- Support improvement initiatives across the organization.
- Lead improvement initiatives across the organization.
- Prepare abstracts, posters, and oral presentations.
- Prepare written reports on clinical programs and studies.
- Communicate clinical results to diverse stakeholders.
Work Experience
- 8 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- CDISC
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Vifor and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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CSCSL Vifor
Associate Director, Biostatistics(m/w/x)
Glattbrugg
Full-timeOn-siteSenior
Nejo AI Summary
Leading biostatistics for innovative therapies in iron deficiency and nephrology, defining strategies for clinical trials and regulatory submissions. 8+ years drug development experience with statistical leadership at compound/indication level required. Global project scope in precision healthcare.
Requirements
- PhD or MS in Biostatistics, Statistics, or related field
- PhD with 8 years or MS with 11 years experience in drug development
- Statistical leadership experience at compound/indication level
- Statistical expertise and leadership in clinical development strategy
- Solid experience in advanced statistical methodologies
- Leading roles in regulatory submissions
- Experience in interactions with major regulatory authorities (preferred)
- Experience with CROs or managing internal deliveries (preferred)
- Track record of innovation (preferred)
- Familiarity with regulatory guidance and interactions
- Broad knowledge of clinical development and processes
- Collaborative work and leadership in matrix environment
- Strong interpersonal and communication skills (verbal and written in English)
- Good working knowledge of SAS and/or R
- Expertise in a range of statistical methodologies
- Innovative/creative methodology for clinical data analysis
- Familiarity with relevant regulatory guidance documents
- Expertise in
- CDISC, statistical programming, and/or data standards
Tasks
- Lead biostatistics for assigned therapeutic programs.
- Define statistical strategies for clinical trials.
- Define statistical strategies for regulatory submissions.
- Ensure appropriate statistical methodologies for study design and data analysis.
- Influence and contribute to clinical development plans.
- Collaborate with cross-functional teams on governance reviews.
- Lead statistical strategy for study planning and execution.
- Lead quantitative evaluations for clinical trials and regulatory submissions.
- Lead quantitative evaluations for related documents.
- Provide statistical thought partnership for innovative study design.
- Provide statistical thought partnership for clinical development plans.
- Develop Go-No Go criteria.
- Perform probability of technical success calculations.
- Plan analyses across all projects.
- Ensure quality and timely delivery of interim results.
- Ensure quality and timely delivery of final results.
- Deliver integrated analyses for submissions.
- Represent Biostatistics to regulatory authorities.
- Interpret analysis results.
- Ensure reporting accuracy in study reports.
- Ensure reporting accuracy in regulatory documents.
- Manage biostatistics outsourcing operations.
- Collaborate with internal statistical programmers.
- Ensure timeliness of CRO/FSP deliverables.
- Ensure quality of CRO/FSP deliverables.
- Support improvement initiatives across the organization.
- Lead improvement initiatives across the organization.
- Prepare abstracts, posters, and oral presentations.
- Prepare written reports on clinical programs and studies.
- Communicate clinical results to diverse stakeholders.
Work Experience
- 8 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- CDISC
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Vifor and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
CSL Vifor
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Partner für pharmazeutische Produkte und innovative Therapien in der Eisenmangel- und Nephrologie.
Not a perfect match?
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